FDA 483 - Roche Diagnostics GmbH - August 01, 2025

Roche Diagnostics GmbH in Penzberg, Germany, received a Form 483 with two observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within 30 days for Elecsys products that produced false reactive test results. Additionally, their procedures for receiving, reviewing, and evaluating complaints were found to be inadequate.